Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.

January 29, 2018 updated by: Knut Taxbro, Linkoeping University
As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Jönköping, Sweden, 551 11
        • Dept of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cancer treatment with need for central venous access
  • Age >18 yrs
  • Suspected survival > 4 weeks
  • Need of central venous access >4 weeks

Exclusion Criteria:

  • Ongoing uncontrolled systemic infection
  • Prescence of significant thrombosis/stenosis in arm or central veins
  • Unability to communicate
  • Probable upcoming need for dialysis fistula

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PICC-line
PICC line insertion.
Device: PICC or subcutaneous venous port
Active Comparator: PORT
Subcutaneous venous port insertion
Device: PICC or subcutaneous venous port

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurence of catheter related venous thrombosis
Time Frame: Upon clinical suspiscion during the one the patient i enrolled in the study
regular follow-ups at month 1, 3, 6 and 12.
Upon clinical suspiscion during the one the patient i enrolled in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Collaborators

Ryhov County Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

January 29, 2018

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • EPN Linkoping 2013/56-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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